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瞩目,石家庄四药又一款高端抗生素申报上市

  • 2026-04-18 01:49:00
瞩目,石家庄四药又一款高端抗生素申报上市
2026年4月17日，据中国国家药品审评中心（CDE）官网最新公示，石家庄四药有限公司按化药注册分类4类申报的注射用替考拉宁上市申请获受理。据公开资料显示，替考拉宁是一种注射糖肽类抗生素，适用于治疗各种严重的革兰阳性菌感 染，包括不能用青霉素类及头孢素类抗生素治疗或上述抗生素治疗失败的严重葡萄球菌感染，或对其他抗生素耐药的葡萄球菌感染等其他感染。
替考拉宁在万古霉素分子结构基础上进行升级，增加了糖基和脂肪酸侧链。其与特定的肽聚糖序列相结合，在细胞壁合成过程中对糖基转移酶的反应和肽聚糖合成的转肽反应进行双重阻断，有强效杀菌作用，且不易发生耐药。替考拉宁的脂肪酸侧链能够增强亲脂性、避免酶解，更有利于药物锚定细菌细胞膜，强化阻断细胞壁合成。
该药为时间依赖性抗菌药物，消除半衰期长达100~170 h。在足量用药，血药浓度达标的情况下，游离药物与血清蛋白结合可形成逐步释放抗生素的缓冲池，长期维持组织和血清药物浓度稳定，维持期每日一次给药。同时，替考拉宁具有良好的组织穿透性，在肺上皮细胞衬液中浓度可达血药浓度的48%~332%，有效针对肺部感染。因此，替考拉宁被认为是一种升级版的糖肽类杀菌剂。
替考拉宁由Hoechst Marion Roussel（德国）研发，后被Aventis并购，现由Sanofi-Aventis进行上市销售。替考拉宁最早于1988年在意大利、法国上市，至2000年12月进入中国市场。2004年03，其最大的竞争对手浙江医药新昌制药厂仿制药获批上市，从此两者开始了长时间的较劲。
国内仿制情况，除原研外，国内已经华北制药、海南倍特药业、浙江海正药业、四川汇宇制药、浙江普利药业、浙江医药股份等11家药企获得注射用替考拉宁生产批文，竞争较为激烈。
据相关数据统计显示，在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，注射用替考拉宁是全身用抗细菌药明星产品，2018年的销售额接近8亿元，随后开始出现下滑态势，2023年销售额止跌回升6.43%，接近5亿元。
近年来，一些抗菌药物的耐药率在持续升高，已逐渐成为新的全球性公共危机。糖肽类抗生素是通过高亲和力结合细菌细胞壁前体肽聚糖的D-丙氨酰-D-丙氨酸末端，阻断转肽酶和羧肽酶活性，抑制细胞壁合成，导致细菌溶解死亡。这一类药物对多数β-内酰胺酶、金属酶稳定，且需细菌改变细胞壁前体结构（如VRE的VanA/B基因）才能产生耐药，天然耐药率显著低于β-内酰胺类。其中的替考拉宁对非抗万古霉素肠球菌仍保持>90%敏感率，是万古霉素耐药率上升的重要替代选择。
在临床抗感染治疗中，替考拉宁对单纯肺炎以及肺炎合并血流感染均适用，有助于全面控制金葡菌感染。临床研究及荟萃分析显示，替考拉宁对中国革兰阳性耐药菌肺部感染患者的疗效较好，治疗时间显著较万古霉素更短。
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2026年石家庄艺术中考时间 #石家庄初三 #石家庄2026年艺术类中考时间

石铁院党委副书记孙冬带队赴石家庄市轨道交通集团有限责任公司访企拓岗

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  1. CONNECT:[ UseTime:0.000856s ] mysql:host=127.0.0.1;port=3306;dbname=nowww460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001314s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000695s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000679s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001330s ]
  6. SELECT * FROM `set` [ RunTime:0.000596s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001462s ]
  8. SELECT * FROM `article` WHERE `id` = 499228 LIMIT 1 [ RunTime:0.010305s ]
  9. UPDATE `article` SET `lasttime` = 1776482015 WHERE `id` = 499228 [ RunTime:0.001596s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000606s ]
  11. SELECT * FROM `article` WHERE `id` < 499228 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000951s ]
  12. SELECT * FROM `article` WHERE `id` > 499228 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000944s ]
  13. SELECT * FROM `article` WHERE `id` < 499228 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.003287s ]
  14. SELECT * FROM `article` WHERE `id` < 499228 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.014996s ]
  15. SELECT * FROM `article` WHERE `id` < 499228 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.015377s ]
0.234759s